Genvoya, a four-component combination pill for HIV-1 treatment, was approved today by the U.S. Food and Drug Administration (FDA).
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Patients taking Genvoya must also be aware they could develop side effects such as liver problems and accumulation of lactic acid in the blood; and therefore must be watched by physicians for these side effects which could be severe in certain cases. It is meant to be a complete Human Immunodeficiency Virus (HIV) treatment regimen for adults and for children 12 years and older.
The CDC estimates that 1.2 million persons ages 13 years and older are living with HIV infection, and that more than another 150,000 persons in this age range have HIV but are unaware of their infection.
The safety and efficacy of the treatment were evaluated in more than 3,100 adults that participated in 4 clinical trials.
Moreover, the Company has also submitted a new drug application (NDA) to the FDA for a once-daily single-tablet regimen comprising its Emtriva and TAF and Johnson & Johnson’s (JNJ) Edurant (rilpivirine). The most common side effect associated with Genvoya is nausea. Results showed Genvoya was effective in reducing viral loads and comparable to the other treatment regimens.
Genvoya is marketed by Gilead Sciences Inc. based in Foster City, California. The FDA encourages doctors and health providers to follow the progress of their patients to contrast this possible side effects. Patients with moderate renal impairment can take Genvoya, according to the FDA approval.
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According to Gilead, Genvoya’s ingredients include elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide, and comes with a few limitations – it can only be used by patients over the age of 12 who weigh at least 77 pounds, and have not had previous HIV treatments. When drugs are delivered inside cells, it reduces the amount of drugs within the bloodstream, and this in turn reduces the chances of kidney damage and compromised bone density among other side effects.It needs to be pointed out that the drug can also cause redistribution of body fat as well as alterations to the immune system, while also capable of interacting with other medicines. Genvoya should not be given with other antiretroviral products and may have drug interactions with a number of other commonly used medications. Last year, the agency sanctioned two drugs by Gilead, Tybost and Vitekta, for treating HIV.
